Overview

Study to Evaluate the Long-Term Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) in Patients Who Require Opioid Treatment for an Extended Period of Time

Status:
Completed

Trial end date:
2012-09-01

Target enrollment:

Participant gender:

Summary

The primary objective of this study is to evaluate the safety of hydrocodone extended-release tablets when used over a 12-month period in patients with chronic pain, as assessed by adverse events, clinical laboratory results, vital signs measurements, electrocardiogram results, physical examination findings, pure tone audiometry, and concomitant medication usage.

Phase:

Phase 3

Details

Lead Sponsor:

Cephalon
Teva Branded Pharmaceutical Products R&D, Inc.

Treatments:

Hydrocodone